# K182308: Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri Trang Gloves (Thailand) Co., Ltd.
- Decided: May 30, 2019 after 279 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device has been tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: The tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/mL, 12.8 minutes breakthrough detection time Cisplatin 1.0 mg/mL, No breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, No breakthrough up to 240 minutes Dacarbazine (DTIC) 10.0 mg/mL, No breakthrough up to 240 minutes Doxorubicin Hydrochloride 2.0 mg/mL, No breakthrough up to 240 minutes Etoposide (Toposar) 20.0 mg/mL, No breakthrough up to 240 minutes Fluorouracil 50.0 mg/mL, No breakthrough up to 240 minutes Methotrexate 25 mg/mL, No breakthrough up to 240 minutes Paclitaxel (Taxol) 6.0 mg/mL, No breakthrough up to 240 minutes Thiotepa 10.0 mg/mL, 4.5 minutes breakthrough detection time Vincristine Sulfate 1.0 mg/mL, No breakthrough up to 240 minutes CAUTION: Carmustine and Thiotepa have low breakthrough times of 12.8 and 4.5 minutes respectively.

Source page: https://510kreport.com/device/K182308
Methodology: https://510kreport.com/methodology